cfr_sections
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:3.0.1.1.3.1.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | A | Subpart A—General Provisions | § 172.5 General provisions for direct food additives. | FDA | (a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purposes of this part, good manufacturing practice shall be defined to include the following restrictions. (1) The quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food. (2) Any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient. (b) The existence of a regulation prescribing safe conditions of use for a food additive shall not be construed to relieve the use of the substance from compliance with any other provision of the Act. (c) The existence of any regulation prescribing safe conditions of use for a nutrient substance does not constitute a finding that the substance is useful or required as a supplement to the diet of humans. | ||||
| 21:21:3.0.1.1.3.2.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.105 Anoxomer. | FDA | [48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989; 88 FR 17719, Mar. 24, 2023] | Anoxomer as identified in this section may be safely used in accordance with the following conditions: (a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4′-(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-57-2) prepared by condensation polymerization of divinylbenzene ( m - and p -) with tert -butylhydroquinone, tert -butylphenol, hydroxyanisole, p -cresol and 4,4′-isopropylidenediphenol. (b) The polymeric antioxidant meets the following specifications: (1) Polymer, not less than 98.0 percent as determined by an ultraviolet method entitled “Ultraviolet Assay, “1982, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) Molecular weight: Total monomers, dimers and trimers below 500 not more than 1 percent as determined by a method entitled “Low Molecular Weight Anoxomer Analysis,” 1982, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (3) Phenol content: Not less than 3.2 milliequivalent/gram and not more than 3.8 milliequivalent/gram as determined by a method entitled “Total Phenols,” 1982, which is incorporated by reference. Copies are available f… | |||
| 21:21:3.0.1.1.3.2.1.10 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.150 4-Hydroxymethyl-2,6-di- | FDA | The food additive 4-hydroxymethyl-2,6-di- tert -butylphenol may be safely used in food in accordance with the following prescribed conditions: (a) The additive has a solidification point of 140 °C-141 °C. (b) The additive is used as an antioxidant alone or in combination with other permitted antioxidants. (c) The total amount of all antioxidants added to such food shall not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food. | ||||
| 21:21:3.0.1.1.3.2.1.11 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.155 Natamycin (pimaricin). | FDA | [47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001; 81 FR 5591, Feb. 3, 2016; 88 FR 17719, Mar. 24, 2023] | (a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is a polyene macrolide antimycotic substance possessing an empirical formula of C 33 H 47 NO 13 and a molecular weight of 665.7. (b) The additive shall conform to the following specifications: Purity: 97 percent ±2 percent on an anhydrous basis. Arsenic: Not more than 1 part per million. Heavy metals (as Pb): Not more than 20 parts per million. Purity: 97 percent ±2 percent on an anhydrous basis. Arsenic: Not more than 1 part per million. Heavy metals (as Pb): Not more than 20 parts per million. (c) The additive may be applied on cheese, as an antimycotic, in amounts not to exceed 20 milligrams per kilogram (20 parts per million) in the finished product as determined by International Dairy Federation (IDF) Standard 140A:1992, “Cheese and Cheese Rind-Determination of Natamycin Content-Method by Molecular Absorption Spectrometry and by High-Performance Liquid Chromatography,” which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. | |||
| 21:21:3.0.1.1.3.2.1.12 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.160 Potassium nitrate. | FDA | The food additive potassium nitrate may be safely used as a curing agent in the processing of cod roe, in an amount not to exceed 200 parts per million of the finished roe. | ||||
| 21:21:3.0.1.1.3.2.1.13 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.165 Quaternary ammonium chloride combination. | FDA | [50 FR 3890, Jan. 29, 1985] | The food additive, quaternary ammonium chloride combination, may be safely used in food in accordance with the following conditions: (a) The additive contains the following compounds: n- dodecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-07-1); n- dodecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-28-3); n- hexadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-18-9); n- octadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-19-0); n- tetradecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-08-2); n- tetradecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-29-4). (b) The additive meets the following specifications: pH (5 percent active solution) 7.0-8.0; total amines, maximum 1 percent as combined free amines and amine hydrochlorides. (c) The additive is used as an antimicrobial agent, as defined in § 170.3(o)(2) of this chapter, in raw sugar cane juice. It is added prior to clarification when further processing of the sugar cane juice must be delayed. (d) The additive is applied to the sugar juice in the following quantities, based on the weight of the raw cane: | |||
| 21:21:3.0.1.1.3.2.1.14 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.167 Silver nitrate and hydrogen peroxide solution. | FDA | [74 FR 11478, Mar. 18, 2009, as amended at 78 FR 71461, Nov. 29, 2013; 81 FR 5591, Feb. 3, 2016; 88 FR 17719, Mar. 24, 2023] | An aqueous solution containing a mixture of silver nitrate and hydrogen peroxide may be safely used in accordance with the following prescribed conditions: (a) The additive is used as an antimicrobial agent in bottled water. (b) Hydrogen peroxide meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 496-497, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (c) The amount of silver added will not exceed 17 micrograms per kilogram in the treated bottled water, and the amount of hydrogen peroxide will not exceed 23 milligrams per kilogram in the treated bottled water. Analyses for silver and hydrogen peroxide shall be conducted on samples of treated bottled water at the site of bottling, using samples of the water intended for treatment for the blank determination. (d)(1) The amount of silver in the treated bottled water is determined using the method for silver designated in 21 CFR 165.110(b)(4)(iii)(G)( 2 )( i ). (2) The amount of hydrogen peroxide in the treated bottled water is determined using a Hydrogen Peroxide Test Kit from the HACH Co., or equivalent. The manual from the Hydrogen Peroxide Test Kit, Model HYP-1, Catalog Number 22917-00, 1991, is incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(… | |||
| 21:21:3.0.1.1.3.2.1.15 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.170 Sodium nitrate. | FDA | The food additive sodium nitrate may be safely used in or on specified foods in accordance with the following prescribed conditions: (a) It is used or intended for use as follows: (1) As a preservative and color fixative, with or without sodium nitrite, in smoked, cured sablefish, smoked, cured salmon, and smoked, cured shad, so that the level of sodium nitrate does not exceed 500 parts per million and the level of sodium nitrite does not exceed 200 parts per million in the finished product. (2) As a preservative and color fixative, with or without sodium nitrite, in meat-curing preparations for the home curing of meat and meat products (including poultry and wild game), with directions for use which limit the amount of sodium nitrate to not more than 500 parts per million in the finished meat product and the amount of sodium nitrite to not more than 200 parts per million in the finished meat product. (b) To assure safe use of the additive, in addition to the other information required by the Act: (1) The label of the additive or of a mixture containing the additive shall bear: (i) The name of the additive. (ii) A statement of the concentration of the additive in any mixture. (2) If in a retail package intended for household use, the label and labeling of the additive, or of a mixture containing the additive, shall bear adequate directions for use to provide a final food product that complies with the limitations prescribed in paragraph (a) of this section. (3) If in a retail package intended for household use, the label of the additive or of a mixture containing the additive, shall bear the statement “Keep out of the reach of children”. | ||||
| 21:21:3.0.1.1.3.2.1.16 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.175 Sodium nitrite. | FDA | The food additive sodium nitrite may be safely used in or on specified foods in accordance with the following prescribed conditions: (a) It is used or intended for use as follows: (1) As a color fixative in smoked cured tunafish products so that the level of sodium nitrite does not exceed 10 parts per million (0.001 percent) in the finished product. (2) As a preservative and color fixative, with or without sodium nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked, cured shad so that the level of sodium nitrite does not exceed 200 parts per million and the level of sodium nitrate does not exceed 500 parts per million in the finished product. (3) As a preservative and color fixative, with sodium nitrate, in meat-curing preparations for the home curing of meat and meat products (including poultry and wild game), with directions for use which limit the amount of sodium nitrite to not more than 200 parts per million in the finished meat product, and the amount of sodium nitrate to not more than 500 parts per million in the finished meat product. (b) To assure safe use of the additive, in addition to the other information required by the Act: (1) The label of the additive or of a mixture containing the additive shall bear: (i) The name of the additive. (ii) A statement of the concentration of the additive in any mixture. (2) If in a retail package intended for household use, the label and labeling of the additive, or of a mixture containing the additive, shall bear adequate directions for use to provide a final food product which complies with the limitations prescribed in paragraph (a) of this section. (3) If in a retail package intended for household use, the label of the additive, or of a mixture containing the additive, shall bear the statement “Keep out of the reach of children”. | ||||
| 21:21:3.0.1.1.3.2.1.17 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.177 Sodium nitrite used in processing smoked chub. | FDA | The food additive sodium nitrite may be safely used in combination with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation from Clostridium botulinum type E in the commercial processing of smoked chub in accordance with the following prescribed conditions: (a) All fish in smoking establishments shall be clean and wholesome and shall be expeditiously processed, packed, and stored under adequate sanitary conditions in accordance with good manufacturing practice. (b) The brining procedure is controlled in such a manner that the water phase portion of the edible portion of the finished smoked product has a salt (NaCl) content of not less than 3.5 percent, as measured in the loin muscle, and the sodium nitrite content of the edible portion of the finished smoked product is not less than 100 parts per million and not greater than 200 parts per million, as measured in the loin muscle. (c) Smoked chub shall be heated by a controlled heat process which provides a monitoring system positioned in as many strategic locations in the smokehouse as necessary to assure a continuous temperature throughout each fish of at least 160 °F for a minimum of 30 minutes. (d) The finished product shall be cooled to a temperature of 50 °F or below within 3 hours after smoking and further cooled to a temperature of 38 °F or below within 12 hours after smoking. A temperature of 38 °F or below shall be maintained during all subsequent storage and distribution. All shipping containers, retail packages, and shipping records shall indicate with appropriate notice the perishable nature of the product and specify that the product shall be held under refrigeration (38 °F or below) until consumed. (e) To assure safe use of the additive: (1) The label and labeling of the additive container shall bear, in addition to the other information required by the Act, the name of the additive. (2) The label or labeling of the additive container shall bear adequate directions to assure use in compliance with the provisions of this sectio… | ||||
| 21:21:3.0.1.1.3.2.1.18 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.180 Stannous chloride. | FDA | The food additive stannous chloride may be safely used for color retention in asparagus packed in glass, with lids lined with an inert material, in an amount not to exceed 20 parts per million calculated as tin (Sn). | ||||
| 21:21:3.0.1.1.3.2.1.19 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.185 TBHQ. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 80 FR 34276, June 16, 2015; 88 FR 17719, Mar. 24, 2023] | The food additive TBHQ, which is the chemical 2-(1,1-dimethylethyl)-1,4-benzenediol (Chemical Abstracts Service Registry Number 1948-33-0), also known as tertiary butylhydroquinone, may be safely used in food in accordance with the following prescribed conditions: (a) The food additive has a melting point of not less than 126.5 °C. (b) The percentage of TBHQ in the food additive is not less than 99.0 percent when tested by the assay described in the Food Chemicals Codex, 9th ed. (2014), pp. 1192-1194, which is incorporated by reference, or an equivalent method. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address: http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html . (c) It is used as an antioxidant alone or in combination with BHA and/or BHT. (d) The total antioxidant content of a food containing the additive will not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food. | |||
| 21:21:3.0.1.1.3.2.1.2 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.110 BHA. | FDA | The food additive BHA (butylated hydroxyanisole) alone or in combination with other antioxidants permitted in food for human consumption in this subpart B may be safely used in or on specified foods, as follows: (a) The BHA meets the following specification: Assay (total BHA), 98.5 percent minimum. Melting point 48 °C minimum. Assay (total BHA), 98.5 percent minimum. Melting point 48 °C minimum. (b) The BHA is used alone or in combination with BHT, as an antioxidant in foods, as follows: 1 BHA only. (c) To assure safe use of the additive: (1) The label of any market package of the additive shall bear, in addition to the other information required by the Act, the name of the additive. (2) When the additive is marketed in a suitable carrier, in addition to meeting the requirement of paragraph (c)(1) of this section, the label shall declare the percentage of the additive in the mixture. (3) The label or labeling of dry mixes for beverages and desserts shall bear adequate directions for use to provide that beverages and desserts prepared from the dry mixes contain no more than 2 parts per million BHA. | ||||
| 21:21:3.0.1.1.3.2.1.20 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.190 THBP. | FDA | The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely used in food in accordance with the following prescribed conditions: (a) The food additive has a melting point of 149 °C-153 °C. (b) It is used as an antioxidant alone or in combination with other permitted antioxidants. (c) The total antioxidant content of a food containing the additive will not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food. | ||||
| 21:21:3.0.1.1.3.2.1.3 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.115 BHT. | FDA | The food additive BHT (butylated hydroxytoluene), alone or in combination with other antioxidants permitted in this subpart B may be safely used in or on specified foods, as follows: (a) The BHT meets the following specification: Assay (total BHT) 99 percent minimum. (b) The BHT is used alone or in combination with BHA, as an antioxidant in foods, as follows: (c) To assure safe use of the additive: (1) The label of any market package of the additive shall bear, in addition to the other information required by the Act, the name of the additive. (2) When the additive is marketed in a suitable carrier, in addition to meeting the requirement of paragraph (c)(1) of this section, the label shall declare the percentage of the additive in the mixture. | ||||
| 21:21:3.0.1.1.3.2.1.4 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.120 Calcium disodium EDTA. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 48 FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, Aug. 8, 2000] | The food additive calcium disodium EDTA (calcium disodium ethylene-diaminetetraacetate) may be safely used in designated foods for the purposes and in accordance with the conditions prescribed, as follows: (a) The additive contains a minimum of 99 percent by weight of either the dihydrate C 10 H 12 O 8 N 2 CaNa 2 ·2H 2 O or the trihydrate C 10 H 12 O 8 N 2 CaNa 2 ·3H 2 O, or any mixture of the two. (b) It is used or intended for use as follows: (1) Alone, in the following foods at not to exceed the levels prescribed, calculated as the anhydrous compound: 1 By weight of egg yolk portion. (2) With disodium EDTA (disodium ethylenediaminetetraacetate) in the following foods at not to exceed, in combination, the levels prescribed, calculated as anhydrous C 10 H 12 O 8 N 2 CaNa 2 : (c) To assure safe use of the additive: (1) The label and labeling of the additive container shall bear, in addition to the other information required by the Act, the name of the additive. (2) The label or labeling of the additive container shall bear adequate use directions to provide a final food product that complies with the limitations provided in paragraph (b) of this section. (d) In the standardized foods listed in paragraph (b) of this section, the additives are used only in compliance with the applicable standards of identity for such foods. | |||
| 21:21:3.0.1.1.3.2.1.5 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.130 Dehydroacetic acid. | FDA | The food additive dehydroacetic acid and/or its sodium salt may be safely used in accordance with the following prescribed conditions: (a) The food additive meets the following specifications: Dehydroacetic acid: Melting point, 109 °C-111 °C; assay, minimum 98 percent (dry basis). Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry basis). Dehydroacetic acid: Melting point, 109 °C-111 °C; assay, minimum 98 percent (dry basis). Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry basis). (b) It is used or intended for use as a preservative for cut or peeled squash, and is so used that no more than 65 parts per million expressed as dehydroacetic acid remains in or on the prepared squash. (c) The label or labeling of any package of the additive intended for use in food shall bear adequate directions for use to insure compliance with this section. | ||||
| 21:21:3.0.1.1.3.2.1.6 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.133 Dimethyl dicarbonate. | FDA | [53 FR 41329, Oct. 21, 1988, as amended at 58 FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, 1996; 66 FR 13653, Mar. 7, 2001; 88 FR 17719, Mar. 24, 2023] | Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in food in accordance with the following prescribed conditions: (a) The additive meets the following specifications: (1) The additive has a purity of not less than 99.8 percent as determined by the following titration method: principles of method Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine with which it reacts quantitatively. The excess amine is backtitrated with acid. apparatus 250-milliliter (mL) Beaker 100-mL Graduate cylinder 25-mL Pipette 10-mL Burette (automatic, e.g., Metrohm burette) Stirrer Device for potentiometric titration Reference electrode Glass electrode reagents Acetone, analytical-grade Solution of 1 N diisobutylamine in chlorobenzene, distilled 1 N Acetic Acid procedure Accurately weigh in about 2 grams of the sample (W) and dissolve in 100 mL acetone. Add accurately 25 mL of the 1 N diisobutylamine solution by pipette and allow to stand for 5 minutes. Subsequently, titrate the reaction mixture potentiometrically with 1 N hydrochloric acid (consumption= a mL) while stirring. For determining the blank consumption, carry out the analysis without a sample (consumption= b mL). calculation Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine with which it reacts quantitatively. The excess amine is backtitrated with acid. 250-milliliter (mL) Beaker 100-mL Graduate cylinder 25-mL Pipette 10-mL Burette (automatic, e.g., Metrohm burette) Stirrer Device for potentiometric titration Reference electrode Glass electrode Acetone, analytical-grade Solution of 1 N diisobutylamine in chlorobenzene, distilled 1 N Acetic Acid Accurately weigh in about 2 grams of the sample (W) and dissolve in 100 mL acetone. Add accurately 25 mL of the 1 N diisobutylamine solution by pipette and allow to stand for 5 minutes. Subsequently, titrate the reaction mixture potentiometrically with 1 N hydrochloric acid (consumption= a mL) while stirring. F… | |||
| 21:21:3.0.1.1.3.2.1.7 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.135 Disodium EDTA. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 65 FR 48379, Aug. 8, 2000] | The food additive disodium EDTA (disodium ethylenediaminetetraacetate) may be safely used in designated foods for the purposes and in accordance with the following prescribed conditions: (a) The additive contains a minimum of 99 percent disodium ethylenedia-minetetraacetate dihydrate (C 10 H 14 O 8 N 2 Na 2 ·2H 2 O). (b) It is used or intended for use as follows: (1) Alone, in the following foods at not to exceed the levels prescribed, calculated as anhydrous calcium disodium EDTA: 1 Based on total weight of finished product including packing medium. 2 In dried banana component of cereal product. (2) With calcium disodium EDTA (calcium disodium ethylenediaminetetraacetate; calcium disodium (ethylenedinitrilo) tetraacetate), in the following foods at not to exceed, in combination, the levels prescribed, calculated as anhydrous C 10 H 12 O 8 N 2 CaNa 2 : (3) Alone, as a sequestrant in the nonnutritive sweeteners that are listed in § 180.37 of this chapter and that, in addition, are designed for aqueous solution: Provided, That the amount of the additive, calculated as anhydrous calcium disodium EDTA, does not exceed 0.1 percent by weight of the dry nonnutritive sweetener. (c) To assure the safe use of the additive: (1) The label and labeling of the additive container shall bear, in addition to the other information required by the act, the name of the additive. (2) The label or labeling of the additive container shall bear adequate use directions to provide a final food product that complies with the limitations provided in paragraph (b) of this section. (d) In the standardized foods listed in paragraphs (b)(1) and (2) of this section the additives are used only in compliance with the applicable standards of identity for such foods. | |||
| 21:21:3.0.1.1.3.2.1.8 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.140 Ethoxyquin. | FDA | (a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be safely used as an antioxidant for preservation of color in the production of chili powder, paprika, and ground chili at levels not in excess of 100 parts per million. (b) In order to provide for the safe use of the additive in feed prepared in accordance with §§ 573.380 and 573.400 of this chapter, tolerances are established for residues of ethoxyquin in or on edible products of animals as follows: 5 parts per million in or on the uncooked fat of meat from animals except poultry. 3 parts per million in or on the uncooked liver and fat of poultry. 0.5 part per million in or on the uncooked muscle meat of animals. 0.5 part per million in poultry eggs. Zero in milk. 5 parts per million in or on the uncooked fat of meat from animals except poultry. 3 parts per million in or on the uncooked liver and fat of poultry. 0.5 part per million in or on the uncooked muscle meat of animals. 0.5 part per million in poultry eggs. Zero in milk. | ||||
| 21:21:3.0.1.1.3.2.1.9 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | B | Subpart B—Food Preservatives | § 172.145 Heptylparaben. | FDA | (a) The food additive heptylparaben is the chemical n -heptyl p -hydroxybenzoate. (b) It may be safely used to inhibit microbiological spoilage in accordance with the following prescribed conditions: (1) In fermented malt beverages in amounts not to exceed 12 parts per million. (2) In noncarbonated soft drinks and fruit-based beverages in amounts not to exceed 20 parts per million, when standards of identity established under section 401 of the Act (21 U.S.C. 341) do not preclude such use. | ||||
| 21:21:3.0.1.1.3.3.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.210 Coatings on fresh citrus fruit. | FDA | [42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 1996] | Coatings may be applied to fresh citrus fruit for protection of the fruit in accordance with the following conditions: (a) The coating is applied in the minimum amount required to accomplish the intended effect. (b) The coating may be formulated from the following components, each used in the minimum quantity required to accomplish the intended effect: (1) Substances generally recognized as safe for the purpose or previously sanctioned for the purpose. (2) One or more of the following: (3) In lieu of the components listed in paragraph (b)(2) and (4) of this section, the following copolymer and one or more of the listed adjuvants. (4) In lieu of the components listed in paragraph (b)(2) and (3) of this section, the following rosin derivative and either or both of the listed adjuvants: | |||
| 21:21:3.0.1.1.3.3.1.10 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.275 Synthetic paraffin and succinic derivatives. | FDA | Synthetic paraffin and succinic derivatives identified in this section may be safely used as a component of food, subject to the following restrictions: (a) The additive is prepared with 50 percent Fischer-Tropsch process synthetic paraffin, meeting the definition and specifications of § 172.615, and 50 percent of such synthetic paraffin to which is bonded succinic anhydride and succinic acid derivatives of isopropyl alcohol, polyethylene glycol, and polypropylene glycol. It consists of a mixture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl succinic anhydride polyethylene glycol half ester, and dialkyl succinic anhydride polypropylene glycol half ester, where the alkane (alkyl) has a chain length of 30-70 carbon atoms and the polyethylene and polypropylene glycols have molecular weights of 600 and 260, respectively. (b) The additive meets the following specifications: Molecular weight, 880-930; melting point, 215°-217 °F; acid number, 43-47; and saponification number, 75-78. (c) It is used or intended for use as a protective coating or component of protective coatings for fresh grapefruit, lemons, limes, muskmelons, oranges, sweetpotatoes, and tangerines. (d) It is used in an amount not to exceed that required to produce the intended effect. | ||||
| 21:21:3.0.1.1.3.3.1.11 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.280 Terpene resin. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984] | The food additive terpene resin may be safely used in accordance with the following prescribed conditions: (a) The food additive is the betapinene polymer obtained by polymerizing terpene hydrocarbons derived from wood. It has a softening point of 112 °C-118 °C, as determined by ASTM method E28-67 (Reapproved 1982), “Standard Test Method for Softening Point By Ring-and-Ball Apparatus,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) It is used or intended for use as follows: (1) As a moisture barrier on soft gelatin capsules in an amount not to exceed 0.07 percent of the weight of the capsule. (2) As a moisture barrier on powders of ascorbic acid or its salts in an amount not to exceed 7 percent of the weight of the powder. | |||
| 21:21:3.0.1.1.3.3.1.2 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.215 Coumarone-indene resin. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984] | The food additive coumarone-indene resin may be safely used on grapefruit, lemons, limes, oranges, tangelos, and tangerines in accordance with the following prescribed conditions: (a) The food additive is manufactured by the polymerization of a crude, heavy coal-tar solvent naphtha meeting the following specifications: (1) It is a mixture of indene, indan (hydrindene), substituted benzenes, and related compounds. (2) It contains no more than 0.25 percent tar bases. (3) 95 percent distills in the range 167 °C-184 °C. (b) The food additive meets the following specifications: (1) Softening point, ring and ball: 126 °C minimum as determined by ASTM method E28-67 (Reapproved 1982), “Standard Test Method for Softening Point by Ring-and-Ball Apparatus,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) Refractive index ( n 25 / D ) 1.63-1.64. (c) It is used or intended for use as a protective coating for grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the maximum amount of the resin remaining on the fruit does not exceed 200 parts per million on a fresh-weight basis. (d) To assure safe use of the additive: (1) The label of the market package or any intermediate premix of the additive shall bear, in addition to the other information required by the act: (i) The name of the additive, coumarone-indene resin. (ii) A statement of the concentration of the additive therein. (2) The label or accompanying labeling shall bear adequate directions that, if followed, will result in a finished food not in conflict with the requirements of this section. | |||
| 21:21:3.0.1.1.3.3.1.3 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils. | FDA | [57 FR 12711, Apr. 13, 1992] | Methyl esters and ethyl esters of fatty acids produced from edible fats and oils may be safely used in food, subject to the following prescribed conditions: (a) The additive consists of a mixture of either methyl or ethyl esters of fatty acids produced from edible fats and oils and meets the following specifications: (1) Not less than 90 percent methyl or ethyl esters of fatty acids. (2) Not more than 1.5 percent unsaponifiable matter. (b) The additive is used or intended for use at the level not to exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 200 parts per million. | |||
| 21:21:3.0.1.1.3.3.1.4 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.230 Microcapsules for flavoring substances. | FDA | [45 FR 48123, July 18, 1980] | Microcapsules may be safely used for encapsulating discrete particles of flavoring substances that are generally recognized as safe for their intended use or are regulated under this part, in accordance with the following conditions: (a) The microcapsules may be formulated from the following components, each used in the minimum quantity required to accomplish the intended effect: (1) Substances generally recognized as safe for the purpose. (2) One or more of the following components: component and limitations Succinylated gelatin—Not to exceed 15 percent by combined weight of the microcapsule and flavoring oil. Succinic acid content of the gelatin is 4.5 to 5.5 percent. Arabinogalactan—Complying with § 172.610; as adjuvant. Silicon dioxide—Complying with § 172.480; as adjuvant. Succinylated gelatin—Not to exceed 15 percent by combined weight of the microcapsule and flavoring oil. Succinic acid content of the gelatin is 4.5 to 5.5 percent. Arabinogalactan—Complying with § 172.610; as adjuvant. Silicon dioxide—Complying with § 172.480; as adjuvant. (3) In lieu of the components listed in paragraph (a)(2) of this section, the following components: component and limitations Glutaraldehyde—As cross-linking agent for insolubilizing a coacervate of gum arabic and gelatin. n -Octyl alcohol—As a defoamer. Glutaraldehyde—As cross-linking agent for insolubilizing a coacervate of gum arabic and gelatin. n -Octyl alcohol—As a defoamer. (4) In lieu of the components listed in paragraphs (a)(2) and (3) of this section, the following component: component and limitations Petroleum wax—Complying with § 172.886. Not to exceed 50 percent by combined weight of the microcapsule and spice-flavoring substance. Petroleum wax—Complying with § 172.886. Not to exceed 50 percent by combined weight of the microcapsule and spice-flavoring substance. (b) The microcapsules produced from the components listed in paragraphs (a)(1), (2), and (3) of this section may be used for encapsulating authorized flavoring oils… | |||
| 21:21:3.0.1.1.3.3.1.5 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.235 Morpholine. | FDA | Morpholine may be safely used as a component of food, subject to the following restrictions. (a) It is used as the salt(s) of one or more of the fatty acids meeting the requirements of § 172.860, as a component of protective coatings applied to fresh fruits and vegetables. (b) It is used at a level not in excess of that reasonably required to produce its intended effect. | ||||
| 21:21:3.0.1.1.3.3.1.6 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.250 Petroleum naphtha. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 88 FR 17719, Mar. 24, 2023] | Petroleum naphtha may be safely used in food in accordance with the following conditions: (a) The additive is a mixture of liquid hydrocarbons, essentially paraffinic and naphthenic in nature obtained from petroleum, (b) The additive is refined to meet the following specifications when subjected to the procedures described in this paragraph. (1) Boiling-point range: 175 °F-300 °F. (2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum. (3) Ultraviolet absorbance limits, as follows: Analytical Specification for Petroleum Naphtha general instructions All glassware should be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure, it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of petroleum naphtha samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light. apparatus Separatory funnels. 250-milliliter, and 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks. Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck. Evaporation flask. 250-milliliter capacity all-glass flask equipped with 24/40 standard taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of the container liquid to be evaporated. Condenser. 24/40 joints, fitted with drying tube, length optional. Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5,000 centimeters ±0.005 centimeter; also for checking spectrophotometer performance only, optical path length in th… | |||
| 21:21:3.0.1.1.3.3.1.7 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.255 Polyacrylamide. | FDA | Polyacrylamide containing not more than 0.2 percent of acrylamide monomer may be safely used as a film former in the imprinting of soft-shell gelatin capsules when the amount used is not in excess of the minimum required to produce the intended effect. | ||||
| 21:21:3.0.1.1.3.3.1.8 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.260 Oxidized polyethylene. | FDA | Oxidized polyethylene may be safely used as a component of food, subject to the following restrictions: (a) Oxidized polyethylene is the basic resin produced by the mild air oxidation of polyethylene. The polyethylene used in the oxidation process conforms to the density, maximum n- hexane extractable fraction, and maximum xylene soluble fraction specifications prescribed in item 2.3 of the table in § 177.1520(c) of this chapter. The oxidized polyethylene has a minimum number average molecular weight of 1,200, as determined by high temperature vapor pressure osmometry; contains a maximum of 5 percent by weight of total oxygen; and has an acid value of 9 to 19. (b) The additive is used or intended for use as a protective coating or component of protective coatings for fresh avocados, bananas, beets, coconuts, eggplant, garlic, grapefruit, lemons, limes, mango, muskmelons, onions, oranges, papaya, peas (in pods), pineapple, plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines, turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts, pecans, and walnuts (all nuts in shells). (c) The additive is used in accordance with good manufacturing practice and in an amount not to exceed that required to produce the intended effect. | ||||
| 21:21:3.0.1.1.3.3.1.9 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | C | Subpart C—Coatings, Films and Related Substances | § 172.270 Sulfated butyl oleate. | FDA | [57 FR 12711, Apr. 13, 1992] | Sulfate butyl oleate may be safely used in food, subject to the following prescribed conditions: (a) The additive is prepared by sulfation, using concentrated sulfuric acid, of a mixture of butyl esters produced by transesterification of an edible vegetable oil using 1-butanol. Following sulfation, the reaction mixture is washed with water and neutralized with aqueous sodium or potassium hydroxide. Prior to sulfation, the butyl oleate reaction mixture meets the following specifications: (1) Not less than 90 percent butyl oleate. (2) Not more than 1.5 percent unsaponifiable matter. (b) The additive is used or intended for use at a level not to exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 100 parts per million. | |||
| 21:21:3.0.1.1.3.4.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.310 Aluminum nicotinate. | FDA | Aluminum nicotinate may be safely used as a source of niacin in foods for special dietary use. A statement of the concentration of the additive, expressed as niacin, shall appear on the label of the food additive container or on that of any intermediate premix prepared therefrom. | ||||
| 21:21:3.0.1.1.3.4.1.10 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.365 Kelp. | FDA | Kelp may be safely added to a food as a source of the essential mineral iodine, provided the maximum intake of the food as may be consumed during a period of one day, or as directed for use in the case of a dietary supplement, will not result in daily ingestion of the additive so as to provide a total amount of iodine in excess of 225 micrograms for foods labeled without reference to age or physiological state; and when age or the conditions of pregnancy or lactation are specified, in excess of 45 micrograms for infants, 105 micrograms for children under 4 years of age, 225 micrograms for adults and children 4 or more years of age, and 300 micrograms for pregnant or lactating women. The food additive kelp is the dehydrated, ground product prepared from Macrocystis pyrifera, Laminaria digitata, Laminaria saccharina, and Laminaria cloustoni. | ||||
| 21:21:3.0.1.1.3.4.1.11 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.370 Iron-choline citrate complex. | FDA | Iron-choline citrate complex made by reacting approximately equimolecular quantities of ferric hydroxide, choline, and citric acid may be safely used as a source of iron in foods for special dietary use. | ||||
| 21:21:3.0.1.1.3.4.1.12 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.372 | FDA | [43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989] | The food additive N -acetyl-L-methionine may be safely added to food (except infant foods and foods containing added nitrites/nitrates) as a source of L-methionine for use as a nutrient in accordance with the following conditions: (a) N- Acetyl-L-methionine (Chemical Abstracts Service Registry No. 65-82-7) is the derivative of the amino acid methionine formed by addition of an acetyl group to the alpha- amino group of methionine. It may be in the free, hydrated or anhydrous form, or as the sodium or potassium salts. (b) The additive meets the following specifications: (1) Purity assay, on a dry basis: Minimum 99 percent. (2) Residue on ignition: Maximum 0.1 percent. (3) Specific optical rotation [alpha] 20 D : Between −19° and −23°. (4) The additive may contain residues of not more than 500 ppm ethyl acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm acetone, when used as processing solvents. (c) The additive is used or intended for use as a source of L-methionine to improve significantly the biological quality of the total protein in a food containing naturally occurring primarily intact vegetable protein that is considered a significant dietary protein source, provided that: (1) A reasonable daily adult intake of the finished food furnishes at least 6.5 grams of naturally occurring primarily intact vegetable protein. (2) The additive results in a protein efficiency ratio (PER) of protein in the finished ready-to-eat food equivalent to casein as determined by the method specified in paragraph (d) of this section. (3) The use of the additive results in a statistically significant increase in the PER as determined by the method described in paragraph (d) of this section. The minimum amount of the additive to achieve the desired effect must be used, and the increase in PER over the primarily intact naturally occurring vegetable protein in the food must be substantiated as a statistically significant difference with at least a probability (P) value of less than 0.05. (4) The amount of th… | |||
| 21:21:3.0.1.1.3.4.1.13 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.375 Potassium iodide. | FDA | The food additive potassium iodide may be safely used in accordance with the following prescribed conditions: (a) Potassium iodide may be safely added to a food as a source of the essential mineral iodine, provided the maximum intake of the food as may be consumed during a period of one day, or as directed for use in the case of a dietary supplement, will not result in daily ingestion of the additive so as to provide a total amount of iodine in excess of 225 micrograms for foods labeled without reference to age or physiological state; and when age or the conditions of pregnancy or lactation are specified, in excess of 45 micrograms for infants, 105 micrograms for children under 4 years of age, 225 micrograms for adults and children 4 or more years of age, and 300 micrograms for pregnant or lactating women. (b) To assure safe use of the additive, in addition to the other information required by the Act, the label of the additive shall bear: (1) The name of the additive. (2) A statement of the concentration of the additive in any mixture. | ||||
| 21:21:3.0.1.1.3.4.1.14 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.379 Vitamin D | FDA | [74 FR 11022, Mar. 16, 2009, as amended at 78 FR 71463, Nov. 29, 2013; 81 FR 46581, July 18, 2016; 88 FR 17719, Mar. 24, 2023] | Vitamin D 2 may be used safely in foods as a nutrient supplement defined under § 170.3(o)(20) of this chapter in accordance with the following prescribed conditions: (a) Vitamin D 2 , also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. Vitamin D 2 is produced by ultraviolet irradiation of ergosterol isolated from yeast and is purified by crystallization. (b) Vitamin D 2 meets the specifications of the 2015 Food Chemical Codex, 9th edition (through Third Supplement), effective December 1, 2015, pp. 1260-1261, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (c) The additive may be used as follows: | |||
| 21:21:3.0.1.1.3.4.1.15 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.380 Vitamin D | FDA | [68 FR 9003, Feb. 27, 2003, as amended at 70 FR 36025, June 22, 2005; 70 FR 37257, June 29, 2005; 70 FR 69438, Nov. 16, 2005; 78 FR 71463, Nov. 29, 2013; 79 FR 46996, Aug. 12, 2014; 81 FR 46582, July 18, 2016; 83 FR 47559, Sept. 20, 2018; 88 FR 749, Jan. 5, 2023; 88 FR 17719, Mar. 24, 2023; 90 FR 42704, Sept. 4, 2025] | Vitamin D 3 may be used safely in foods as a nutrient supplement defined under § 170.3(o)(20) of this chapter in accordance with the following prescribed conditions: (a) Vitamin D 3 , also known as cholecalciferol, is the chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin D 3 occurs in and is isolated from fish liver oils. It also is manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced from cholesterol and is purified by crystallization. (b) Vitamin D 3 meets the specifications of Vitamin D 3 , Food Chemicals Codex, 14th edition, effective June 1, 2024, which is incorporated by reference into this section. The Director of the Federal Register approved this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA at: the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday; phone: 240-402-7500; email: IBR_Material_Inquiries@fda.hhs.gov. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email fr.inspection@nara.gov. This material may be obtained from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852; phone 800-822-8772; email fcc@usp.org; website: https://www.usp.org. (c) The additive may be used as follows: (1) At levels not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 330 milligrams (mg) of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants. (2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks (as defined under § 170.3(n)(35) of this cha… | |||
| 21:21:3.0.1.1.3.4.1.16 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.381 Vitamin D | FDA | [77 FR 52231, Aug. 29, 2012] | Vitamin D 2 bakers yeast may be used safely in foods as a source of vitamin D 2 and as a leavening agent in accordance with the following prescribed conditions: (a) Vitamin D 2 bakers yeast is the substance produced by exposing bakers yeast ( Saccharomyces cerevisiae ) to ultraviolet light, resulting in the photochemical conversion of endogenous ergosterol in bakers yeast to vitamin D 2 (also known as ergocalciferol or (9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol)). (b) Vitamin D 2 bakers yeast may be used alone as an active dry yeast concentrate or in combination with conventional bakers yeast. (c) The additive may be used in yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods at levels not to exceed 400 International Units of vitamin D 2 per 100 grams in the finished food. (d) To assure safe use of the additive, the label or labeling of the food additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions for use to provide a final product that complies with the limitations prescribed in paragraph (c) of this section. (e) Labels of manufactured food products containing the additive shall bear, in the ingredient statement, the name of the additive, “vitamin D 2 bakers yeast,” in the proper order of decreasing predominance in the finished food. | |||
| 21:21:3.0.1.1.3.4.1.17 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.382 Vitamin D | FDA | [85 FR 41920, July 13, 2020] | Vitamin D 2 mushroom powder may be used safely in foods as a source of vitamin D 2 in accordance with the following prescribed conditions: (a) Vitamin D 2 mushroom powder is the substance produced by exposing an aqueous homogenate of edible cultivars of Agaricus bisporus mushrooms to ultraviolet (UV) light, resulting in the photochemical conversion of endogenous ergosterol in the mushrooms to vitamin D 2 (also known as ergocalciferol or [9,10-Seco(5Z,7E,22E)-5,7,10(19),22- ergostatetraen-3-ol]). (b) The total dose of UV light applied to the mushroom homogenate shall not exceed 12 Joules/square centimeter (J/cm 2 ). (c) Vitamin D 2 mushroom powder meets the following specifications: (1) Moisture, not more than 10 percent. (2) Negative for Salmonella, Staphylococcus aureus, and Listeria monocytogenes, and any other recognized microbial pathogen or any harmful microbial toxin. (3) Standard plate count, not more than 5,000 colony forming units per gram (CFU/g). (4) Yeasts and molds, not more than 100 CFU/g. (5) Lead, not more than 0.5 milligrams per kilogram (mg/kg). (6) Arsenic, not more than 0.3 mg/kg. (d) To assure safe use of the additive, the label or labeling of the food additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions for use to provide a final product that complies with the limitations prescribed in paragraph (f) of this section. (e) Labels of manufactured food products containing the additive shall bear, in the ingredient statement, the name of the additive “vitamin D 2 mushroom powder,” in the proper order of decreasing predominance in the finished food. (f) Vitamin D 2 mushroom powder may be used as a source of vitamin D 2 in food as follows: Table 1 to Paragraph ( f ) | |||
| 21:21:3.0.1.1.3.4.1.18 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.385 Whole fish protein concentrate. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989] | The food additive whole fish protein concentrate may be safely used as a food supplement in accordance with the following prescribed conditions: (a) The additive is derived from whole, wholesome hake and hakelike fish, herring of the genera Clupea, menhaden, and anchovy of the species Engraulis mordax, handled expeditiously and under sanitary conditions in accordance with good manufacturing practices recognized as proper for fish that are used in other forms for human food. (b) The additive consists essentially of a dried fish protein processed from the whole fish without removal of heads, fins, tails, viscera, or intestinal contents. It is prepared by solvent extraction of fat and moisture with isopropyl alcohol or with ethylene dichloride followed by isopropyl alcohol, except that the additive derived from herring, menhaden and anchovy is prepared by solvent extraction with isopropyl alcohol alone. Solvent residues are reduced by conventional heat drying and/or microwave radiation and there is a partial removal of bone. (c) The food additive meets the following specifications: (1) Protein content (N × 6.25) shall not be less than 75 percent by weight of the final product, as determined by the method described in section 2.057 in “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), 13th Ed. (1980). Protein quality shall not be less than 100, as determined by the method described in sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by reference, and copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) Moisture content shall not exceed 10 percent by weight of the final product, as determined by the method described in section 24.003 of … | |||
| 21:21:3.0.1.1.3.4.1.19 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.395 Xylitol. | FDA | Xylitol may be safely used in foods for special dietary uses, provided the amount used is not greater than that required to produce its intended effect. | ||||
| 21:21:3.0.1.1.3.4.1.2 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.315 Nicotinamide-ascorbic acid complex. | FDA | Nicotinamide-ascorbic acid complex may be safely used in accordance with the following prescribed conditions: (a) The additive is the product of the controlled reaction between ascorbic acid and nicotinamide, melting in the range 141 °C to 145 °C. (b) It is used as a source of ascorbic acid and nicotinamide in multivitamin preparations. | ||||
| 21:21:3.0.1.1.3.4.1.20 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.399 Zinc methionine sulfate. | FDA | [46 FR 58297, Dec. 1, 1981] | Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used in accordance with the following prescribed conditions: (a) The additive is the product of the reaction between equimolar amounts of zinc sulfate and DL-methionine in purified water. (b) The additive meets the following specifications: Zinc content—19 to 22 percent. C 5 H 11 NO 2 S “DL-methionine”—46 to 50 percent. Cadmium—not more than 0.05 part per million. Zinc content—19 to 22 percent. C 5 H 11 NO 2 S “DL-methionine”—46 to 50 percent. Cadmium—not more than 0.05 part per million. (c) The additive is used in tablet form as a source of dietary zinc. | |||
| 21:21:3.0.1.1.3.4.1.3 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.320 Amino acids. | FDA | [78 FR 71461, Nov. 29, 2013, as amended at 88 FR 17719, Mar. 24, 2023] | The food additive amino acids may be safely used as nutrients added to foods in accordance with the following conditions: (a) The food additive consists of one or more of the following individual amino acids in the free, hydrated, or anhydrous form, or as the hydrochloride, sodium, or potassium salts: (1) L-Alanine (2) L-Arginine (3) L-Asparagine (4) L-Aspartic acid (5) L-Cysteine (6) L-Cystine (7) L-Glutamic acid (8) L-Glutamine (9) Aminoacetic acid (glycine) (10) L-Histidine (11) L-Isoleucine (12) L-Leucine (13) L-Lysine (14) DL-Methionine (not for infant foods) (15) L-Methionine (16) L-Phenylalanine (17) L-Proline (18) L-Serine (19) L-Threonine (20) L-Tryptophan (21) L-Tyrosine (22) L-Valine (b) The food additive meets the following specifications: (1) As found in Food Chemicals Codex: (i) L-Alanine, pages 28 and 29. (ii) L-Arginine, pages 69 and 70. (iii) L-Arginine Monohydrochloride, pages 70 and 71. (iv) L-Cysteine Monohydrochloride, pages 269 and 270. (v) L-Cystine, pages 270 and 271. (vi) Aminoacetic acid (glycine), pages 457 and 458. (vii) L-Leucine, pages 577 and 578. (viii) DL-Methionine, pages 641 and 642. (ix) L-Methionine, pages 642 and 643. (x) L-Tryptophan, pages 1060 and 1061. (xi) L-Phenylalanine, pages 794 and 795. (xii) L-Proline, pages 864 and 865. (xiii) L-Serine, pages 915 and 916. (xiv) L-Threonine, pages 1031 and 1032. (xv) L-Glutamic Acid Hydrochloride, page 440. (xvi) L-Isoleucine, pages 544 and 545. (xvii) L-Lysine Monohydrochloride, pages 598 and 599. (xviii) Monopotassium L -glutamate, pages 697 and 698. (xix) L-Tyrosine, page 1061. (xx) L-Valine, pages 1072. (2) As found in “Specifications and Criteria for Biochemical Compounds,” NAS/NRC Publication, for the following: (i) L-Asparagine (ii) L-Aspartic acid (iii) L-Glutamine (iv) L-Histidine (c) The additive(s) is used or intended for use to significantly improve the biological quality of the total protein in a food containing naturally occurring primarily intact protein that is con… | |||
| 21:21:3.0.1.1.3.4.1.4 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.325 Bakers yeast protein. | FDA | Bakers yeast protein may be safely used in food in accordance with the following conditions: (a) Bakers yeast protein is the insoluble proteinaceous material remaining after the mechanical rupture of yeast cells of Saccharomyces cerevisiae and removal of whole cell walls by centrifugation and separation of soluble cellular materials. (b) The additive meets the following specifications on a dry weight basis: (1) Zinc salts less than 500 parts per million (ppm) as zinc. (2) Nucleic acid less than 2 percent. (3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05 ppm mercury, and 0.3 ppm selenium. (c) The viable microbial content of the finished ingredient is: (1) Less than 10,000 organisms/gram by aerobic plate count. (2) Less than 10 yeasts and molds/gram. (3) Negative for Salmonella, E. coli, coagulase positive Staphylococci, Clostridium perfringens, Clostridium botulinum, or any other recognized microbial pathogen or any harmful microbial toxin. (d) The ingredient is used in food as a nutrient supplement as defined in § 170.3(o)(20) of this chapter. | ||||
| 21:21:3.0.1.1.3.4.1.5 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.330 Calcium pantothenate, calcium chloride double salt. | FDA | The food additive calcium chloride double salt of calcium pantothenate may be safely used in foods for special dietary uses in accordance with good manufacturing practice and under the following prescribed conditions: (a) The food additive is of the d (dextrorotatory) or the dl (racemic) form. (b) To assure safe use of the additive, the label and labeling of the food additive container, or that of any intermediate premixes prepared therefrom, shall bear, in addition to the other information required by the Act, the following: (1) The name of the additive “calcium chloride double salt of d- calcium pantothenate” or “calcium chloride double salt of dl- calcium pantothenate”, whichever is appropriate. (2) A statement of the appropriate concentration of the additive, expressed as pantothenic acid. | ||||
| 21:21:3.0.1.1.3.4.1.6 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.335 D-Pantothenamide. | FDA | The food additive D-pantothenamide as a source of pantothenic acid activity, may be safely used in foods for special dietary use in an amount not in excess of that reasonably required to produce its intended effect. | ||||
| 21:21:3.0.1.1.3.4.1.7 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.340 Fish protein isolate. | FDA | [46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, 1989] | (a) The food additive fish protein isolate may be safely used as a food supplement in accordance with the following prescribed conditions: (1) The additive shall consist principally of dried fish protein prepared from the edible portions of fish after removal of the heads, fins, tails, bones, scales, viscera, and intestinal contents. (2) The additive shall be derived only from species of bony fish that are generally recognized by qualified scientists as safe for human consumption and that can be processed as prescribed to meet the required specifications. (3) Only wholesome fresh fish otherwise suitable for human consumption may be used. The fish shall be handled expeditiously under sanitary conditions. These conditions shall be in accordance with recognized good manufacturing practice for fish to be used as human food. (4) The additive shall be prepared by extraction with hexane and food-grade ethanol to remove fat and moisture. Solvent residues shall be reduced by drying. (b) The food additive meets the following specifications: (Where methods of determination are specified, they are Association of Official Analytical Chemists Methods, 13th ed., 1980, which are incorporated by reference). 1 1 Copies are available from: AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (1) Protein content, as N × 6.25, shall not be less than 90 percent by weight of the final product, as determined by the method described in section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20)—Official Final Action. (2) Moisture content shall not be more than 10 percent by weight of the final product, as determined by the method described in section 24.003, Air Drying (1)—Official First Action. (3) Fat content shall not be more than 0.5 pe… | |||
| 21:21:3.0.1.1.3.4.1.8 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.345 Folic acid (folacin). | FDA | [61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999; 78 FR 71463, Nov. 29, 2013; 81 FR 22183, Apr. 15, 2016; 88 FR 17719, Mar. 24, 2023] | Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, may be safely used in food as a nutrient in accordance with the following prescribed conditions: (a) Folic acid is the chemical N -[4-[[(2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]- L -glutamic acid. (b) Folic acid meets the specifications of the Food Chemicals Codex, 9th ed., updated through Third Supplement, effective December 1, 2015, pp. 495-496, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (c) Folic acid may be added to foods subject to a standard of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act (the act) when the standard of identity specifically provides for the addition of folic acid. (d) Folic acid may be added, at levels not to exceed 400 micrograms (µg) per serving, to breakfast cereals, as defined under § 170.3(n)(4) of this chapter, and to corn grits at a level such that each pound of corn grits contains not more than 1.0 milligram of folic acid. (e) Folic acid may be added to infant formula in accordance with section 412(i)(1) of the act or with regulations issued under section 412(i)(2) of the act which are codified in § 107.100 of this chapter. (f) Folic acid may be added to a medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)… | |||
| 21:21:3.0.1.1.3.4.1.9 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | D | Subpart D—Special Dietary and Nutritional Additives | § 172.350 Fumaric acid and salts of fumaric acid. | FDA | Fumaric acid and its calcium, ferrous, magnesium, potassium, and sodium salts may be safely used in food in accordance with the following prescribed conditions: (a) The additives meet the following specifications: (1) Fumaric acid contains a minimum of 99.5 percent by weight of fumaric acid, calculated on the anhydrous basis. (2) The calcium, magnesium, potassium, and sodium salts contain a minimum of 99 percent by weight of the respective salt, calculated on the anhydrous basis. Ferrous fumarate contains a minimum of 31.3 percent total iron and not more than 2 percent ferric iron. (b) With the exception of ferrous fumarate, fumaric acid and the named salts are used singly or in combination in food at a level not in excess of the amount reasonably required to accomplish the intended effect. (c) Ferrous fumarate is used as a source of iron in foods for special dietary use, when the use is consistent with good nutrition practice. | ||||
| 21:21:3.0.1.1.3.5.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | E | Subpart E—Anticaking Agents | § 172.410 Calcium silicate. | FDA | Calcium silicate, including synthetic calcium silicate, may be safely used in food in accordance with the following prescribed conditions: (a) It is used as an anticaking agent in food in an amount not in excess of that reasonably required to produce its intended effect. (b) It will not exceed 2 percent by weight of the food, except that it may be present up to 5 percent by weight of baking powder. | ||||
| 21:21:3.0.1.1.3.5.1.2 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | E | Subpart E—Anticaking Agents | § 172.430 Iron ammonium citrate. | FDA | Iron ammonium citrate may be safely used in food in accordance with the following prescribed conditions: (a) The additive is the chemical green ferric ammonium citrate. (b) The additive is used, or intended for use as an anticaking agent in salt for human consumption so that the level of iron ammonium citrate does not exceed 25 parts per million (0.0025 percent) in the finished salt. (c) To assure safe use of the additive the label or labeling of the additive shall bear, in addition to the other information required by the Act: (1) The name of the additive. (2) Adequate directions to provide a final product that complies with the limitations prescribed in paragraph (b) of this section. | ||||
| 21:21:3.0.1.1.3.5.1.3 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | E | Subpart E—Anticaking Agents | § 172.480 Silicon dioxide. | FDA | The food additive silicon dioxide may be safely used in food in accordance with the following conditions: (a) The food additive is manufactured by vapor phase hydrolysis or by other means whereby the particle size is such as to accomplish the intended effect. (b) It is used as an anticaking agent, subject to the following conditions: (1) It is used in only those foods in which the additive has been demonstrated to have an anticaking effect. (2) It is used in an amount not in excess of that reasonably required to produce its intended effect. (3) [Reserved] (4) It is used in an amount not to exceed 2 percent by weight of the food. (c) It is used or intended for use as a stabilizer in the production of beer, and is removed from the beer by filtration prior to final processing. (d) It is used or intended for use as an adsorbent for dl-a- tocopheryl acetate and pantothenyl alcohol in tableted foods for special dietary use, in an amount not greater than that required to accomplish the intended physical or technical effect. | ||||
| 21:21:3.0.1.1.3.5.1.4 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | E | Subpart E—Anticaking Agents | § 172.490 Yellow prussiate of soda. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 58 FR 17098, Apr. 1, 1993] | (a) The food additive yellow prussiate of soda (sodium ferrocyanide decahydrate; Na 4 Fe(CN) 6 ·10H 2 O contains a minimum of 99 percent by weight of sodium ferrocyanide decahydrate. (b) The additive is used or intended for use as an anticaking agent in salt and as an adjuvant in the production of dendritic crystals of salt in an amount needed to produce its intended effect but not in excess of 13 parts per million calculated as anhydrous sodium ferrocyanide. | |||
| 21:21:3.0.1.1.3.6.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.510 Natural flavoring substances and natural substances used in conjunction with flavors. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 69 FR 24511, May 4, 2004; 72 FR 10357, Mar. 8, 2007] | Natural flavoring substances and natural adjuvants may be safely used in food in accordance with the following conditions. (a) They are used in the minimum quantity required to produce their intended physical or technical effect and in accordance with all the principles of good manufacturing practice. (b) In the appropriate forms (plant parts, fluid and solid extracts, concentrates, absolutes, oils, gums, balsams, resins, oleoresins, waxes, and distillates) they consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, previously sanctioned for such use, or regulated in any section of this part. 1 As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. | |||
| 21:21:3.0.1.1.3.6.1.10 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.585 Sugar beet extract flavor base. | FDA | Sugar beet extract flavor base may be safely used in food in accordance with the provisions of this section. (a) Sugar beet extract flavor base is the concentrated residue of soluble sugar beet extractives from which sugar and glutamic acid have been recovered, and which has been subjected to ion exchange to minimize the concentration of naturally occurring trace minerals. (b) It is used as a flavor in food. | ||||
| 21:21:3.0.1.1.3.6.1.11 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.590 Yeast-malt sprout extract. | FDA | Yeast-malt sprout extract, as described in this section, may be safely used in food in accordance with the following prescribed conditions: (a) The additive is produced by partial hydrolysis of yeast extract (derived from Saccharomyces cereviseae, Saccharomyces fragilis, or Candida utilis ) using the sprout portion of malt barley as the source of enzymes. The additive contains a maximum of 6 percent 5′ nucleotides by weight. (b) The additive may be used as a flavor enhancer in food at a level not in excess of that reasonably required to produce the intended effect. | ||||
| 21:21:3.0.1.1.3.6.1.2 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.515 Synthetic flavoring substances and adjuvants. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 42 FR 23148, May 6, 1977; 43 FR 19843, May 9, 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984; 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, 1989; 61 FR 14245, Apr. 1, 1996; 69 FR 24511, May 4, 2004; 83 FR 50490, 50503, Oct. 9, 2018] | Synthetic flavoring substances and adjuvants may be safely used in food in accordance with the following conditions. (a) They are used in the minimum quantity required to produce their intended effect, and otherwise in accordance with all the principles of good manufacturing practice. (b) They consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, prior-sanctioned for such use, or regulated by an appropriate section in this part. Acetal; acetaldehyde diethyl acetal. Acetaldehyde phenethyl propyl acetal. Acetanisole; 4′-methoxyacetophenone. Acetophenone; methyl phenyl ketone. Allyl anthranilate. Allyl butyrate. Allyl cinnamate. Allyl cyclohexaneacetate. Allyl cyclohexanebutyrate. Allyl cyclohexanehexanoate. Allyl cyclohexaneproprionate. Allyl cyclohexanevalerate. Allyl disulfide. Allyl 2-ethylbutyrate. Allyl hexanoate; allyl caproate. Allyl α-ionone; 1-(2,6,6-trimethyl-2-cyclo-hexene-1-yl)-1,6-heptadiene-3-one. Allyl isothiocyanate; mustard oil. Allyl isovalerate. Allyl mercaptan; 2-propene-1-thiol. Allyl nonanoate. Allyl octanoate. Allyl phenoxyacetate. Allyl phenylacetate. Allyl propionate. Allyl sorbate; allyl 2,4-hexadienoate. Allyl sulfide. Allyl tiglate; allyl trans- 2-methyl-2-butenoate. Allyl 10-undecenoate. Ammonium isovalerate. Ammonium sulfide. Amyl alcohol; pentyl alcohol. Amyl butyrate. α-Amylcinnamaldehyde. α-Amylcinnamaldehyde dimethyl acetal. α-Amylcinnamyl acetate. α-Amylcinnamyl alcohol. α-Amylcinnamyl formate. α-Amylcinnamyl isovalerate. Amyl formate. Amyl heptanoate. Amyl hexanoate. Amyl octanoate. Anisole; methoxybenzene. Anisyl acetate. Anisyl alcohol; p- methoxybenzyl alcohol. Anisyl butyrate Anisyl formate. Anisyl phenylacetate. Anisyl propionate. Beechwood creosote. Benzaldehyde dimethyl acetal. Benzaldehyde glyceryl acetal; 2-phenyl -m- dioxa… | |||
| 21:21:3.0.1.1.3.6.1.3 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.520 Cocoa with dioctyl sodium sulfosuccinate for manufacturing. | FDA | The food additive “cocoa with dioctyl sodium sulfosuccinate for manufacturing,” conforming to § 163.117 of this chapter and § 172.810, is used or intended for use as a flavoring substance in dry beverage mixes whereby the amount of dioctyl sodium sulfosuccinate does not exceed 75 parts per million of the finished beverage. The labeling of the dry beverage mix shall bear adequate directions to assure use in compliance with this section. | ||||
| 21:21:3.0.1.1.3.6.1.4 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.530 Disodium guanylate. | FDA | Disodium guanylate may be safely used as a flavor enhancer in foods, at a level not in excess of that reasonably required to produce the intended effect. | ||||
| 21:21:3.0.1.1.3.6.1.5 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.535 Disodium inosinate. | FDA | The food additive disodium inosinate may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is the disodium salt of inosinic acid, manufactured and purified so as to contain no more than 150 parts per million of soluble barium in the compound disodium inosinate with seven and one-half molecules of water of crystallization. (b) The food additive is used as a flavoring adjuvant in food. | ||||
| 21:21:3.0.1.1.3.6.1.6 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.540 DL-Alanine. | FDA | [56 FR 6968, Feb. 21, 1991] | DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No. 302-72-7) may be safely used as a flavor enhancer for sweeteners in pickling mixtures at a level not to exceed 1 percent of the pickling spice that is added to the pickling brine. | |||
| 21:21:3.0.1.1.3.6.1.7 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.560 Modified hop extract. | FDA | The food additive modified hop extract may be safely used in beer in accordance with the following prescribed conditions: (a) The food additive is used or intended for use as a flavoring agent in the brewing of beer. (b) The food additive is manufactured by one of the following processes: (1) The additive is manufactured from a hexane extract of hops by simultaneous isomerization and selective reduction in an alkaline aqueous medium with sodium borohydride, whereby the additive meets the following specifications: (i) A solution of the food additive solids is made up in approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This absorbance is obtained by approximately 0.03 milligram solids permilliliter.) The ultraviolet absorption spectrum of this solution exhibits the following characteristics: An absorption peak at 253 millimicrons; no absorption peak at 325 to 330 millimicrons; the absorbance at 268 millimicrons does not exceed the absorbance at 272 millimicrons. (ii) The boron content of the food additive does not exceed 310 parts per million (0.0310 percent), calculated as boron. (2) The additive is manufactured from hops by a sequence of extractions and fractionations, using benzene, light petroleum spirits, and methyl alcohol as solvents, followed by isomerization by potassium carbonate treatment. Residues of solvents in the modified hop extract shall not exceed 1.0 part per million of benzene, 1.0 part per million of light petroleum spirits, and 250 parts per million of methyl alcohol. The light petroleum spirits and benzene solvents shall comply with the specifications in § 172.250 except that the boiling point range for light petroleum spirits is 150 °F-300 °F. (3) The additive is manufactured from hops by a sequence of extractions and fractionations, using methylene chloride, hexane, and methyl alcohol as solvents, followed by isomerization by… | ||||
| 21:21:3.0.1.1.3.6.1.8 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.575 Quinine. | FDA | Quinine, as the hydrochloride salt or sulfate salt, may be safely used in food in accordance with the following conditions: | ||||
| 21:21:3.0.1.1.3.6.1.9 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | F | Subpart F—Flavoring Agents and Related Substances | § 172.580 Safrole-free extract of sassafras. | FDA | The food additive safrole-free extract of sassafras may be safely used in accordance with the following prescribed conditions: (a) The additive is the aqueous extract obtained from the root bark of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae). (b) It is obtained by extracting the bark with dilute alcohol, first concentrating the alcoholic solution by vacuum distillation, then diluting the concentrate with water and discarding the oily fraction. (c) The purified aqueous extract is safrole-free. (d) It is used as a flavoring in food. | ||||
| 21:21:3.0.1.1.3.7.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.610 Arabinogalactan. | FDA | Arabinogalactan may be safely used in food in accordance with the following conditions: (a) Arabinogalactan is a polysaccharide extracted by water from Western larch wood, having galactose units and arabinose units in the approximate ratio of six to one. (b) It is used in the following foods in the minimum quantity required to produce its intended effect as an emulsifier, stabilizer, binder, or bodying agent: Essential oils, nonnutritive sweeteners, flavor bases, nonstandardized dressings, and pudding mixes. | ||||
| 21:21:3.0.1.1.3.7.1.2 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.615 Chewing gum base. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, July 23, 2001; 66 FR 53711, Oct. 24, 2001] | The food additive chewing gum base may be safely used in the manufacture of chewing gum in accordance with the following prescribed conditions: (a) The food additive consists of one or more of the following substances that meet the specifications and limitations prescribed in this paragraph, used in amounts not to exceed those required to produce the intended physical or other technical effect. Masticatory Substances natural (coagulated or concentrated latices) of vegetable origin (b) In addition to the substances listed in paragraph (a) of this section, chewing gum base may also include substances generally recognized as safe in food. (c) To assure safe use of the additive, in addition to the other information required by the act, the label and labeling of the food additive shall bear the name of the additive, “chewing gum base.” As used in this paragraph, the term “chewing gum base” means the manufactured or partially manufactured nonnutritive masticatory substance comprised of one or more of the ingredients named and so defined in paragraph (a) of this section. | |||
| 21:21:3.0.1.1.3.7.1.3 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.620 Carrageenan. | FDA | The food additive carrageenan may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is the refined hydrocolloid prepared by aqueous extraction from the following members of the families Gigartinaceae and Solieriaceae of the class Rodophyceae (red seaweed): Chondrus crispus. Chondrus ocellatus. Eucheuma cottonii. Eucheuma spinosum. Gigartina acicularis. Gigartina pistillata. Gigartina radula. Gigartina stellata. Chondrus crispus. Chondrus ocellatus. Eucheuma cottonii. Eucheuma spinosum. Gigartina acicularis. Gigartina pistillata. Gigartina radula. Gigartina stellata. (b) The food additive conforms to the following conditions: (1) It is a sulfated polysaccharide the dominant hexose units of which are galactose and anhydrogalactose. (2) Range of sulfate content: 20 percent to 40 percent on a dry-weight basis. (c) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use. (d) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the additive, carrageenan. | ||||
| 21:21:3.0.1.1.3.7.1.4 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.623 Carrageenan with polysorbate 80. | FDA | Carrageenan otherwise meeting the definition and specifications of § 172.620 (a) and (b) and salts of carrageenan otherwise meeting the definition of § 172.626(a) may be safely produced with the use of polysorbate 80 meeting the specifications and requirements of § 172.840 (a) and (b) in accordance with the following prescribed conditions: (a) The polysorbate 80 is used only to facilitate separation of sheeted carrageenan and salts of carrageenan from drying rolls. (b) The carrageenan and salts of carrageenan contain not more than 5 percent by weight of polysorbate 80, and the final food containing the additives contains polysorbate 80 in an amount not to exceed 500 parts per million. (c) The carrageenan and salts of carrageenan so produced are used only in producing foods in gel form and only for the purposes defined in §§ 172.620(c) and 172.626(b), respectively. (d) The carrageenan and salts of carrageenan so produced are not used in foods for which standards of identity exist unless the standards provide for the use of carrageenan, or salts of carrageenan, combined with polysorbate 80. (e) The carrageenan and salts of carrageenan produced in accordance with this section, and foods containing the same, in addition to the other requirements of the Act, are labeled to show the presence of polysorbate 80, and the label or labeling of the carrageenan and salts of carrageenan so produced bear adequate directions for use. | ||||
| 21:21:3.0.1.1.3.7.1.5 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.626 Salts of carrageenan. | FDA | The food additive salts of carrageenan may be safely used in food in accordance with the following prescribed conditions: (a) The food additive consists of carrageenan, meeting the provisions of § 172.620, modified by increasing the concentration of one of the naturally occurring salts (ammonium, calcium, potassium, or sodium) of carrageenan to the level that it is the dominant salt in the additive. (b) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use. (c) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the salt of carrageenan that dominates the mixture by reason of the modification, e.g., “sodium carrageenan”, “potassium carrageenan”, etc. | ||||
| 21:21:3.0.1.1.3.7.1.6 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.655 Furcelleran. | FDA | The food additive furcelleran may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is the refined hydrocolloid prepared by aqueous extraction of furcellaria fastigiata of the class Rodophyceae (red seaweed). (b) The food additive conforms to the following: (1) It is a sulfated polysaccharide the dominant hexose units of which are galactose and anhydrogalactose. (2) Range of sulfate content: 8 percent to 19 percent, on a dry-weight basis. (c) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use. (d) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the additive, furcelleran. | ||||
| 21:21:3.0.1.1.3.7.1.7 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.660 Salts of furcelleran. | FDA | The food additive salts of furcelleran may be safely used in food in accordance with the following prescribed conditions: (a) The food additive consists of furcelleran, meeting the provisions of § 172.655, modified by increasing the concentration of one of the naturally occurring salts (ammonium, calcium, potassium, or sodium) of furcelleran to the level that it is the dominant salt in the additive. (b) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use. (c) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the salt of furcelleran that dominates the mixture by reason of the modification, e.g., “sodium furcelleran”, “potassium furcelleran”, etc. | ||||
| 21:21:3.0.1.1.3.7.1.8 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.665 Gellan gum. | FDA | [55 FR 39614, Sept. 28, 1990, as amended at 57 FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, 1999; 78 FR 71463, Nov. 29, 2013; 88 FR 17719, Mar. 24, 2023] | The food additive gellan gum may be safely used in food in accordance with the following prescribed conditions: (a) The additive is a high molecular weight polysaccharide gum produced from Pseudomonas elodea by a pure culture fermentation process and purified by recovery with isopropyl alcohol. It is composed of tetrasaccharide repeat units, each containing one molecule of rhamnose and glucuronic acid, and two molecules of glucose. The glucuronic acid is neutralized to a mixed potassium, sodium, calcium, and magnesium salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. (b) The strain of P. elodea is nonpathogenic and nontoxic in man and animals. (c) The additive is produced by a process that renders it free of viable cells of P. elodea. (d) The additive meets the following specifications: (1) Positive for gellan gum when subjected to the following identification tests: (i) A 1-percent solution is made by hydrating 1 gram of gellan gum in 99 milliliters of distilled water. The mixture is stirred for about 2 hours, using a motorized stirrer and a propeller-type stirring blade. A small amount of the above solution is drawn into a wide bore pipet and transferred into a solution of 10-percent calcium chloride. A tough worm-like gel will form instantly. (ii) To the 1-percent distilled water solution prepared for identification test (i), 0.50 gram of sodium chloride is added. The solution is heated to 80 °C with stirring, held at 80 °C for 1 minute, and allowed to cool to room temperature without stirring. A firm gel will form. (2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as determined by the procedure described in the “Gellan gum” monograph in the Food Chemicals Codex, 7th ed. (2010), pp. 425-426, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacop… | |||
| 21:21:3.0.1.1.3.7.1.9 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | G | Subpart G—Gums, Chewing Gum Bases and Related Substances | § 172.695 Xanthan gum. | FDA | The food additive xanthan gum may be safely used in food in accordance with the following prescribed conditions: (a) The additive is a polysaccharide gum derived from Xanthomonas campestris by a pure-culture fermentation process and purified by recovery with isopropyl alcohol. It contains D-glucose, D-mannose, and D-glucuronic acid as the dominant hexose units and is manufactured as the sodium, potassium, or calcium salt. (b) The strain of Xanthomonas campestris is nonpathogenic and nontoxic in man or other animals. (c) The additive is produced by a process that renders it free of viable cells of Xanthomonas campestris. (d) The additive meets the following specifications: (1) Residual isopropyl alcohol not to exceed 750 parts per million. (2) An aqueous solution containing 1 percent of the additive and 1 percent of potassium chloride stirred for 2 hours has a minimum viscosity of 600 centipoises at 75 °F, as determined by Brookfield Viscometer, Model LVF (or equivalent), using a No. 3 spindle at 60 r.p.m., and the ratio of viscosities at 75 °F and 150 °F is in the range of 1.02 to 1.45. (3) Positive for xanthan gum when subjected to the following procedure: Locust Bean Gum Gel Test Blend on a weighing paper or in a weighing pan 1.0 gram of powdered locust bean gum with 1.0 gram of the powdered polysaccharide to be tested. Add the blend slowly (approximately 1/2 minute) at the point of maximum agitation to a stirred solution of 200 milliliters of distilled water previously heated to 80 °C in a 400-milliliter beaker. Continue mechanical stirring until the mixture is in solution, but stir for a minimum time of 30 minutes. Do not allow the water temperature to drop below 60 °C. Set the beaker and its contents aside to cool in the absence of agitation. Allow a minimum time of 2 hours for cooling. Examine the cooled beaker contents for a firm rubbery gel formation after the temperature drops below 40 °C. In the event that a gel is obtained, make up a 1 percent solution of the polysaccharide to … | ||||
| 21:21:3.0.1.1.3.8.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.710 Adjuvants for pesticide use dilutions. | FDA | The following surfactants and related adjuvants may be safely added to pesticide use dilutions by a grower or applicant prior to application to the growing crop: n- Alkyl (C 8 -C 18 ) amine acetate, where the alkyl groups (C 8 -C 18 ) are derived from coconut oil, as a surfactant in emulsifier blends at levels not in excess of 5 percent by weight of the emulsifier blends that are added to herbicides for application to corn and sorghum. Di -n- alkyl (C 8 -C 18 ) dimethyl ammonium chloride, where the alkyl groups (C 8 -C 18 ) are derived from coconut oil, as surfactants in emulsifier blends at levels not in excess of 5 percent by weight of emulsifier blends that are added to herbicides for application to corn or sorghum. Diethanolamide condensate based on a mixture of saturated and unsaturated soybean oil fatty acids (C 16 -C 18 ) as a surfactant in emulsifier blends that are added to the herbicide atrazine for application to corn. Diethanolamide condensate based on stripped coconut fatty acids (C 10 C 18 ) as a surfactant in emulsifier blends that are added to the herbicide atrazine for application to corn. α-( p- Dodecylphenyl) -omega- hydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a proplyene tetramer isomer) with an average of 4-14 or 30-70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4-14 or 30-70. Ethylene dichloride. Polyglyceryl phthalate ester of coconut oil fatty acids. α-[ p- (1,1,3,3-Tetramethylbutyl) phenyl] -omega- hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p- (1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4-14 or 30-70. α-[ p- (1,1,3,3-Tetramethy… | ||||
| 21:21:3.0.1.1.3.8.1.10 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.755 Stearyl monoglyceridyl citrate. | FDA | The food additive stearyl monoglyceridyl citrate may be safely used in food in accordance with the following provisions: (a) The additive is prepared by controlled chemical reaction of the following: (b) The additive stearyl monoglyceridyl citrate, produced as described under paragraph (a) of this section, meets the following specifications: Acid number 40 to 52. Total citric acid 15 to 18 percent. Saponification number 215-255. Acid number 40 to 52. Total citric acid 15 to 18 percent. Saponification number 215-255. (c) The additive is used or intended for use as an emulsion stabilizer in or with shortenings containing emulsifiers. | ||||
| 21:21:3.0.1.1.3.8.1.11 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.765 Succistearin (stearoyl propylene glycol hydrogen succinate). | FDA | The food additive succistearin (stearoyl propylene glycol hydrogen succinate) may be safely used in food in accordance with the following prescribed conditions: (a) The additive is the reaction product of succinic anhydride, fully hydrogenated vegetable oil (predominantly C 16 or C 18 fatty acid chain length), and propylene glycol. (b) The additive meets the following specifications: Acid number 50-150. Hydroxyl number 15-50. Succinated ester content 45-75 percent. Acid number 50-150. Hydroxyl number 15-50. Succinated ester content 45-75 percent. (c) The additive is used or intended for use as an emulsifier in or with shortenings and edible oils intended for use in cakes, cake mixes, fillings, icings, pastries, and toppings, in accordance with good manufacturing practice. | ||||
| 21:21:3.0.1.1.3.8.1.12 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.770 Ethylene oxide polymer. | FDA | The polymer of ethylene oxide may be safely used as a foam stabilizer in fermented malt beverages in accordance with the following conditions. (a) It is the polymer of ethylene oxide having a minimum viscosity of 1,500 centipoises in a 1 percent aqueous solution at 25 °C. (b) It is used at a level not to exceed 300 parts per million by weight of the fermented malt beverage. (c) The label of the additive bears directions for use to insure compliance with paragraph (b) of this section. | ||||
| 21:21:3.0.1.1.3.8.1.13 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.775 Methacrylic acid-divinylbenzene copolymer. | FDA | Methacrylic acid-divinylbenzene copolymer may be safely used in food in accordance with the following prescribed conditions: (a) The additive is produced by the polymerization of methacrylic acid and divinylbenzene. The divinylbenzene functions as a cross-linking agent and constitutes a minimum of 4 percent of the polymer. (b) Aqueous extractives from the additive do not exceed 2 percent (dry basis) after 24 hours at 25 °C. (c) The additive is used as a carrier of vitamin B 12 in foods for special dietary use. | ||||
| 21:21:3.0.1.1.3.8.1.14 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.780 Acacia (gum arabic). | FDA | [70 FR 8034, Feb. 17, 2005, as amended at 78 FR 71464, Nov. 29, 2013; 78 FR 73437, Dec. 6, 2013; 88 FR 17720, Mar. 24, 2023] | The food additive may be safely used in food in accordance with the following prescribed conditions: (a) Acacia (gum arabic) is the dried gummy exudate from stems and branches of trees of various species of the genus Acacia , family Leguminosae. (b) The ingredient meets the specifications of the Food Chemicals Codex, 8th ed. (2012), p. 516, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address: http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (c) The ingredient is used in food in accordance with good manufacturing practices under the following conditions: Maximum Usage Levels Permitted | |||
| 21:21:3.0.1.1.3.8.1.15 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.785 | FDA | [71 FR 47731, Aug. 18, 2006, as amended at 81 FR v5591, Feb. 3, 2016; 88 FR 17720, Mar. 24, 2023] | The additive may be safely used as an antimicrobial agent specific for Listeria monocytogenes ( L. monocytogenes ) in accordance with the following conditions: (a) Identity. (1) The additive consists of a mixture of equal proportions of six different individually purified lytic-type (lacking lysogenic activity) bacteriophages (phages) specific against L. monocytogenes. (2) Each phage is deposited at, and assigned an identifying code by, a scientifically-recognized culture collection center, and is made available to FDA upon request. (3) The additive is produced from one or more cell cultures of L. monocytogenes in a safe and suitable nutrient medium. (b) Specifications. (1) The additive achieves a positive lytic result (OD 600 ≤0.06) when tested against any of the following L. monocytogenes isolates available from American Type Culture Collection (ATCC): ATCC 35152 (serogroup 1/2a), ATCC 19118 (serogroup 4b), and ATCC 15313 (serogroup 1/2b). The analytical method for determining the potency of the additive entitled “Determination of Potency of LMP-102 TM ,” dated October 9, 2003, and printed by Intralytix, Inc., is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or you may examine a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) The mean phage titer of each monophage in the additive is … | |||
| 21:21:3.0.1.1.3.8.1.2 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.712 1,3-Butylene glycol. | FDA | [62 FR 26228, May 13, 1997, as amended at 78 FR 14664, Mar. 7, 2013; 78 FR 71463, Nov. 29, 2013; 88 FR 17719, Mar. 24, 2023] | The food additive 1,3-butylene glycol (CAS Reg. No. 107-88-0) may be safely used in food in accordance with the following prescribed conditions: (a) It is prepared by the aldol condensation of acetaldehyde followed by catalytic hydrogenation. (b) The food additive shall conform to the identity and specifications of the Food Chemicals Codex, 7th ed. (2010), p. 126, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (c) It is used in the manufacture of sausage casings as a formulation aid as defined in § 170.3(o)(14) of this chapter and as a processing aid as defined in § 170.3(o)(24) of this chapter. | |||
| 21:21:3.0.1.1.3.8.1.3 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.715 Calcium lignosulfonate. | FDA | Calcium lignosulfonate may be safely used in or on food, subject to the provisions of this section. (a) Calcium lignosulfonate consists of sulfonated lignin, primarily as calcium and sodium salts. (b) It is used in an amount not to exceed that reasonably required to accomplish the intended physical or technical effect when added as a dispersing agent and stabilizer in pesticides for preharvest or postharvest application to bananas. | ||||
| 21:21:3.0.1.1.3.8.1.4 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.720 Calcium lactobionate. | FDA | The food additive calcium lactobionate may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is the calcium salt of lactobionic acid (4-(β,D-galactosido)-D-gluconic acid) produced by the oxidation of lactose. (b) It is used or intended for use as a firming agent in dry pudding mixes at a level not greater than that required to accomplish the intended effect. | ||||
| 21:21:3.0.1.1.3.8.1.5 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.723 Epoxidized soybean oil. | FDA | [60 FR 32903, June 26, 1995, as amended at 64 FR 1759, Jan. 12, 1999; 78 FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016; 88 FR 17719, Mar. 24, 2023] | Epoxidized soybean oil may be safely used in accordance with the following prescribed conditions: (a) The additive is prepared by reacting soybean oil in toluene with hydrogen peroxide and formic acid. (b) It meets the following specifications: (1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and 8.0 percent, as determined by the American Oil Chemists' Society (A.O.C.S.) method Cd 9-57, “Oxirane Oxygen,” reapproved 1989, which is incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR part 51. Copies are available from the American Oil Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) The maximum iodine value is 3.0, as determined by A.O.C.S. method Cd 1-25, “Iodine Value of Fats and Oils Wijs Method,” revised 1993, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section. (3) The heavy metals (as Pb) content cannot be more than 10 parts per million, as determined by the “Heavy Metals Test,” of the “Food Chemicals Codex,” 4th ed. (1996), pp. 760-761, Method II (with a 2-gram sample and 20 microgram of lead ion in the control), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu ), or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD … | |||
| 21:21:3.0.1.1.3.8.1.6 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.725 Gibberellic acid and its potassium salt. | FDA | The food additives gibberellic acid and its potassium salt may be used in the malting of barley in accordance with the following prescribed conditions: (a) The additives meet the following specifications: (1) The gibberellic acid is produced by deep-culture fermentation of a suitable nutrient medium by a strain of Fusarium moniliforme or a selection of this culture. (2) The gibberellic acid produced is of 80 percent purity or better. (3) The empirical formula of gibberellic acid is represented by C 19 H 22 O 6 . (4) Potassium gibberellate is the potassium salt of the specified gibberellic acid. (5) The potassium gibberellate is of 80 percent purity or better. (6) The gibberellic acid or potassium gibberellate may be diluted with substances generally recognized as safe in foods or with salts of fatty acids conforming to § 172.863. (b) They are used or intended for use in the malting of barley under conditions whereby the amount of either or both additives present in the malt is not in excess of 2 parts per million expressed as gibberellic acid, and the treated malt is to be used in the production of fermented malt beverages or distilled spirits only, whereby the finished distilled spirits contain none and the finished malt beverage contains not more than 0.5 part per million of gibberellic acid. (c) To insure the safe use of the food additives the label of the package shall bear, in addition to the other information required by the Act: (1) The name of the additive, “gibberellic acid” or “potassium gibberellate”, whichever is appropriate. (2) An accurate statement of the concentration of the additive contained in the package. (3) Adequate use directions to provide not more than 2 parts per million of gibberellic acid in the finished malt. (4) Adequate labeling directions to provide that the final malt is properly labeled as described in paragraph (d) of this section. (d) To insure the safe use of the additive the label of the treated malt shall bear, in addition to the other information required by t… | ||||
| 21:21:3.0.1.1.3.8.1.7 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.730 Potassium bromate. | FDA | The food additive potassium bromate may be safely used in the malting of barley under the following prescribed conditions: (a)(1) It is used or intended for use in the malting of barley under conditions whereby the amount of the additive present in the malt from the treatment does not exceed 75 parts per million of bromate (calculated as Br), and the treated malt is used only in the production of fermented malt beverages or distilled spirits. (2) The total residue of inorganic bromides in fermented malt beverages, resulting from the use of the treated malt plus additional residues of inorganic bromides that may be present from uses in accordance with other regulations in this chapter promulgated under sections 408 and/or 409 of the act, does not exceed 25 parts per million of bromide (calculated as Br). No tolerance is established for bromide in distilled spirits because there is evidence that inorganic bromides do not pass over in the distillation process. (b) To assure safe use of the additive, the label or labeling of the food additive shall bear, in addition to the other information required by the Act, the following: (1) The name of the additive. (2) Adequate directions for use. (c) To assure safe use of the additive, the label or labeling of the treated malt shall bear, in addition to other information required by the Act, the statement, “Brewer's Malt—To be used in the production of fermented malt beverages only”, or “Distiller's Malt—To be used in the production of distilled spirits only”, whichever is the case. | ||||
| 21:21:3.0.1.1.3.8.1.8 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.735 Glycerol ester of rosin. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 70 FR 15758, Mar. 29, 2005; 72 FR 46896, Aug. 22, 2007] | Glycerol ester of wood rosin, gum rosin, or tall oil rosin may be safely used in food in accordance with the following prescribed conditions: (a) It has an acid number of 3 to 9, a drop-softening point of 88 to 96 °C; and a color of N or paler as determined in accordance with Official Naval Stores Standards of the United States. It is purified by countercurrent steam distillation or steam stripping. (b) It is used to adjust the density of citrus oils used in the preparation of beverages whereby the amount of the additive does not exceed 100 parts per million of the finished beverage. | |||
| 21:21:3.0.1.1.3.8.1.9 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | H | Subpart H—Other Specific Usage Additives | § 172.736 Glycerides and polyglycides of hydrogenated vegetable oils. | FDA | [71 FR 12620, Mar. 13, 2006, as amended at 78 FR 71463, Nov. 29, 2013; 81 FR 5591, Feb. 3, 2016; 88 FR 17720, Mar. 24, 2023] | The food additive glycerides and polyglycides of hydrogenated vegetable oils may be safely used in food in accordance with the following prescribed conditions: (a) The additive is manufactured by heating a mixture of hydrogenated oils of vegetable origin and polyethylene glycol in the presence of an alkaline catalyst followed by neutralization with any acid that is approved or is generally recognized as safe for this use to yield the finished product. (b) The additive consists of a mixture of mono-, di- and tri-glycerides and polyethylene glycol mono- and di-esters of fatty acids (polyglycides) of hydrogenated vegetable oils and meets the following specifications: (1) Total ester content, greater than 90 percent as determined by a method entitled “Determination of Esterified Glycerides and Polyoxyethylene Glycols,” approved November 16, 2001, printed by Gattefosse S.A.S., and incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200 or you may examine a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) Acid value, not greater than 2, and hydroxyl value, not greater than 56, as determined by the methods entitled “Acid Value,” p. 1220 and “Hydroxyl Value,” p. 1223, respectively, in the Food Chemicals Codex, 7th ed. (2010), which is incorporated by reference. The Director of the Office of the Federal Register approves … | |||
| 21:21:3.0.1.1.3.9.1.1 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.800 Acesulfame potassium. | FDA | [53 FR 28382, July 28, 1988, as amended at 57 FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545, Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR 36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003; 78 FR 71464, Nov. 29, 2013; 88 FR 17720, Mar. 24, 2023] | Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as acesulfame K, may be safely used as a general-purpose sweetener and flavor enhancer in foods generally, except in meat and poultry, in accordance with current good manufacturing practice and in an amount not to exceed that reasonably required to accomplish the intended technical effect in foods for which standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use, under the following conditions: (a) Acesulfame potassium is the potassium salt of 6-methyl-1,2,3-oxathiazine-4(3 H )-one-2,2-dioxide. (b) The additive meets the following specifications: (1) Purity is not less than 99 percent on a dry basis. The purity shall be determined by a method titled “Acesulfame Potassium Assay,” which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) Fluoride content is not more than 30 milligrams per kilogram, as determined by method III of the Fluoride Limit Test of the Food Chemicals Codex, 7th ed. (2010), p. 1151, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or… | |||
| 21:21:3.0.1.1.3.9.1.10 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.812 Glycine. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984; 78 FR 71464, Nov. 29, 2013; 88 FR 17720, Mar. 24, 2023] | The food additive glycine may be safely used for technological purposes in food in accordance with the following prescribed conditions: (a) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 457-458, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (b) The additive is used or intended for use as follows: (c) To assure safe use of the additive, in addition to the other information required by the Act: (1) The labeling of the additive shall bear adequate directions for use of the additive in compliance with the provisions of this section. (2) The labeling of beverage bases containing the additive shall bear adequate directions for use to provide that beverages prepared therefrom shall contain no more than 0.2 percent glycine. | |||
| 21:21:3.0.1.1.3.9.1.11 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.814 Hydroxylated lecithin. | FDA | The food additive hydroxylated lecithin may be safely used as an emulsifier in foods in accordance with the following conditions: (a) The additive is obtained by the treatment of lecithin in one of the following ways, under controlled conditions whereby the separated fatty acid fraction of the resultant product has an acetyl value of 30 to 38: (1) With hydrogen peroxide, benzoyl peroxide, lactic acid, and sodium hydroxide. (2) With hydrogen peroxide, acetic acid, and sodium hydroxide. (b) It is used or intended for use, in accordance with good manufacturing practice, as an emulsifier in foods, except for those standardized foods that do not provide for such use. (c) To assure safe use of the additive, the label of the food additive container shall bear, in addition to the other information required by the Act: (1) The name of the additive, “hydroxylated lecithin”. (2) Adequate directions for its use. | ||||
| 21:21:3.0.1.1.3.9.1.12 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.816 Methyl glucoside-coconut oil ester. | FDA | Methyl glucoside-coconut oil ester may be safely used in food in accordance with the following conditions: (a) It is the methyl glucoside-coconut oil ester having the following specifications: Acid number: 10-20 Hydroxyl number: 200-300 pH (5% aqueous): 4.8-5.0 Saponification number: 178-190 Acid number: 10-20 Hydroxyl number: 200-300 pH (5% aqueous): 4.8-5.0 Saponification number: 178-190 (b) It is used or intended for use as follows: (1) As an aid in crystallization of sucrose and dextrose at a level not to exceed the minimum quantity required to produce its intended effect. (2) As a surfactant in molasses at a level not to exceed 320 parts per million in the molasses. | ||||
| 21:21:3.0.1.1.3.9.1.13 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.818 Oxystearin. | FDA | The food additive oxystearin may be safely used in foods, when such use is not precluded by standards of identity in accordance with the following conditions: (a) The additive is a mixture of the glycerides of partially oxidized stearic and other fatty acids obtained by heating hydrogenated cottonseed or soybean oil under controlled conditions, in the presence of air and a suitable catalyst which is not a food additive as so defined. The resultant product meets the following specifications: Acid number: Maximum 15. Iodine number: Maximum 15. Saponification number: 225-240. Hydroxyl number: 30-45. Unsaponifiable material: Maximum 0.8 percent. Refractive index (butyro): 60±1 at 48 °C. Acid number: Maximum 15. Iodine number: Maximum 15. Saponification number: 225-240. Hydroxyl number: 30-45. Unsaponifiable material: Maximum 0.8 percent. Refractive index (butyro): 60±1 at 48 °C. (b) It is used or intended for use as a crystallization inhibitor in vegetable oils and as a release agent in vegetable oils and vegetable shortenings, whereby the additive does not exceed 0.125 percent of the combined weight of the oil or shortening. (c) To insure safe use of the additive, the label and labeling of the additive container shall bear, in addition to the other information required by the Act: (1) The name of the additive. (2) Adequate directions to provide an oil or shortening that complies with the limitations prescribed in paragraph (b) of this section. | ||||
| 21:21:3.0.1.1.3.9.1.14 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.820 Polyethylene glycol (mean molecular weight 200-9,500). | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984] | Polyethylene glycol identified in this section may be safely used in food in accordance with the following prescribed conditions: (a) Identity. (1) The additive is an addition polymer of ethylene oxide and water with a mean molecular weight of 200 to 9,500. (2) It contains no more than 0.2 percent total by weight of ethylene and diethylene glycols when tested by the analytical methods prescribed in paragraph (b) of this section. (b) Analytical method. (1) The analytical method prescribed in the National Formulary XV (1980), page 1244, for polyethylene glycol 400 shall be used to determine the total ethylene and diethylene glycol content of polyethylene glycols having mean molecular weights of 450 or higher. (2) The following analytical method shall be used to determine the total ethylene and diethylene glycol content of polyethylene glycols having mean molecular weights below 450. Analytical Method ethylene glycol and diethylene glycol content of polyethylene glycols The analytical method for determining ethylene glycol and diethylene glycol is as follows: apparatus Gas chromatograph with hydrogen flame ionization detector (Varian Aerograph 600 D or equivalent). The following conditions shall be employed with the Varian Aerograph 600 D gas chromatograph: Column temperature: 165 °C. Inlet temperature: 260 °C. Carrier gas (nitrogen) flow rate: 70 milliliters per minute. Hydrogen and air flow to burner: Optimize to give maximum sensitivity. Sample size: 2 microliters. Elution time: Ethylene glycol: 2.0 minutes. Diethylene glycol: 6.5 minutes. Recorder: −0.5 to + 1.05 millivolt, full span, 1 second full response time. Syringe: 10-microliter (Hamilton 710 N or equivalent). Chromatograph column: 5 feet × 1/8 inch. I.D. stainless steel tube packed with sorbitol (Mathieson-Coleman-Bell 2768 Sorbitol SX850, or equivalent) 12 percent in H 2 O by weight on 60-80 mesh nonacid washed diatomaceous earth (Chromosorb W. Johns-Manville, or equivalent). reagents and materials … | |||
| 21:21:3.0.1.1.3.9.1.15 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.822 Sodium lauryl sulfate. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 43 FR 18668, May 2, 1978] | The food additive sodium lauryl sulfate may be safely used in food in accordance with the following conditions: (a) The additive meets the following specifications: (1) It is a mixture of sodium alkyl sulfates consisting chiefly of sodium lauryl sulfate [CH 2 (CH 2 ) 10 CH 2 OSO 2 Na]. (2) It has a minimum content of 90 percent sodium alkyl sulfates. (b) It is used or intended for use: (1) As an emulsifier in or with egg whites whereby the additive does not exceed the following limits: Egg white solids, 1,000 parts per million. Frozen egg whites, 125 parts per million. Liquid egg whites, 125 parts per million. Egg white solids, 1,000 parts per million. Frozen egg whites, 125 parts per million. Liquid egg whites, 125 parts per million. (2) As a whipping agent at a level not to exceed 0.5 percent by weight of gelatine used in the preparation of marshmallows. (3) As a surfactant in: (i) Fumaric acid-acidulated dry beverage base whereby the additive does not exceed 25 parts per million of the finished beverage and such beverage base is not for use in a food for which a standard of identity established under section 401 of the Act precludes such use. (ii) Fumaric acid-acidulated fruit juice drinks whereby the additive does not exceed 25 parts per million of the finished fruit juice drink and it is not used in a fruit juice drink for which a standard of identity established under section 401 of the Act precludes such use. (4) As a wetting agent at a level not to exceed 10 parts per million in the partition of high and low melting fractions of crude vegetable oils and animal fats, provided that the partition step is followed by a conventional refining process that includes alkali neutralization and deodorization of the fats and oils. (c) To insure the safe use of the additive, the label of the food additive container shall bear, in addition to the other information required by the Act: (1) The name of the additive, sodium lauryl sulfate. (2) Adequate use directions to provide a final product that … | |||
| 21:21:3.0.1.1.3.9.1.16 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.824 Sodium mono- and dimethyl naphthalene sulfonates. | FDA | [42 FR 14491, Mar. 15, 1977, as amended at 63 FR 7069, Feb. 12, 1998] | The food additive sodium mono- and dimethyl naphthalene sulfonates may be safely used in accordance with the following prescribed conditions: (a) The additive has a molecular weight range of 245-260. (b) The additive is used or intended for use: (1) In the crystallization of sodium carbonate in an amount not to exceed 250 parts per million of the sodium carbonate. Such sodium carbonate is used or intended for use in potable water systems to reduce hardness and aid in sedimentation and coagulation by raising the pH for the efficient utilization of other coagulation materials. (2) As an anticaking agent in sodium nitrite at a level not in excess of 0.1 percent by weight thereof for authorized uses in cured fish and meat. (c) In addition to the general labeling requirements of the Act: (1) Sodium carbonate produced in accordance with paragraph (b)(1) of this section shall be labeled to show the presence of the additive and its label or labeling shall bear adequate directions for use. (2) Sodium nitrite produced in accordance with paragraph (b)(2) of this section shall bear the labeling required by § 172.175 and a statement declaring the presence of sodium mono- and dimethyl naphthalene sulfonates. | |||
| 21:21:3.0.1.1.3.9.1.17 | 21 | Food and Drugs | I | B | 172 | PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION | I | Subpart I—Multipurpose Additives | § 172.826 Sodium stearyl fumarate. | FDA | Sodium stearyl fumarate may be safely used in food in accordance with the following conditions: (a) It contains not less than 99 percent sodium stearyl fumarate calculated on the anhydrous basis, and not more than 0.25 percent sodium stearyl maleate. (b) The additive is used or intended for use: (1) As a dough conditioner in yeast-leavened bakery products in an amount not to exceed 0.5 percent by weight of the flour used. (2) As a conditioning agent in dehydrated potatoes in an amount not to exceed 1 percent by weight thereof. (3) As a stabilizing agent in nonyeast-leavened bakery products in an amount not to exceed 1 percent by weight of the flour used. (4) As a conditioning agent in processed cereals for cooking in an amount not to exceed 1 percent by weight of the dry cereal, except for foods for which standards of identity preclude such use. (5) As a conditioning agent in starch-thickened or flour-thickened foods in an amount not to exceed 0.2 percent by weight of the food. |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);